Sign in

You're signed outSign in or to get full access.

SCYNEXIS (SCYX)

--

Earnings summaries and quarterly performance for SCYNEXIS.

Recent press releases and 8-K filings for SCYX.

SCYNEXIS Receives FDA Designations for SCY-247
SCYX
New Projects/Investments
  • SCYNEXIS has been granted Qualified Infectious Disease Product (QIDP) and Fast Track Designations by the U.S. Food and Drug Administration (FDA) for its second-generation triterpenoid antifungal therapy, SCY-247.
  • The QIDP designation will ensure at least 10 years of market exclusivity for SCY-247 following approval.
  • In 2026, the company expects to initiate a Phase 1 study of SCY-247 with the IV formulation and a Phase 2 study with the oral formulation in invasive candidiasis (IC), also aiming to release proof-of-concept data for the oral formulation in IC.
  • SCY-247 is being developed to address the serious unmet need posed by life-threatening resistant fungal infections, including multi-drug resistant Candida auris.
Jan 21, 2026, 1:00 PM
SCYNEXIS Granted Nasdaq Extension for Minimum Bid Price Compliance
SCYX
Delisting/Listing Issues
New Projects/Investments
  • SCYNEXIS, Inc. received an additional 180-calendar-day extension from Nasdaq to regain compliance with the minimum bid price requirement.
  • The new deadline for the company to maintain a closing bid price of at least $1.00 per share for a minimum of ten consecutive business days is June 15, 2026.
  • Nasdaq granted the extension after determining SCYNEXIS meets all other continued listing criteria and has provided notice of its intention to cure the deficiency, potentially through a reverse stock split.
  • SCYNEXIS plans to leverage its balance sheet to complete a Phase 1 study of an intravenous (IV) formulation for SCY-247 and generate proof-of-concept Phase 2 data for the oral formulation of SCY-247 for invasive candidiasis infections.
Dec 22, 2025, 1:00 PM
SCYNEXIS and GSK Settle Brexafemme Trial Dispute
SCYX
Legal Proceedings
Product Launch
New Projects/Investments
  • GlaxoSmithKline (GSK) paid Scynexis $22 million, plus an additional $2.3 million for wind-down activities, to resolve their dispute over the Phase 3 MARIO study of Brexafemme for invasive candidiasis.
  • Scynexis will terminate the MARIO study, but the companies will continue their collaboration on the commercialization of Brexafemme for vulvovaginal candidiasis (VVC) and refractory VVC.
  • Scynexis will transfer Brexafemme's regulatory application to GSK, which plans to engage with the FDA in 2026 to discuss the drug's relaunch in the U.S. market.
  • Scynexis continues to develop its second-generation triterpenoid antifungal candidate, SCY-247, aimed at treating and preventing invasive fungal infections.
Oct 15, 2025, 1:23 PM
SCYNEXIS and GSK Amend Exclusive License Agreement, Resolve MARIO Study Disagreement
SCYX
Legal Proceedings
New Projects/Investments
  • SCYNEXIS, Inc. and GlaxoSmithKline Intellectual Property (No. 3) Limited (GSK) entered into a binding memorandum of understanding on October 14, 2025, to resolve a disagreement concerning the Phase 3 MARIO study of ibrexafungerp.
  • Under the terms of the agreement, SCYNEXIS will wind-down and terminate the MARIO Study and will receive a $22 million payment from GSK, in addition to $2.3 million for wind-down and termination activities.
  • SCYNEXIS will not receive any further milestone payments specifically related to the MARIO Study.
  • GSK has reaffirmed its commitment to continued collaboration on other aspects of the Exclusive License Agreement, including the commercialization of BREXAFEMME® for VVC and rVVC indications.
  • SCYNEXIS is on track to transfer the BREXAFEMME NDA to GSK by the end of 2025, with GSK anticipating initiating regulatory interactions with the U.S. Food and Drug Administration (FDA) in 2026 to discuss the relaunch of BREXAFEMME in the U.S. market.
Oct 15, 2025, 12:00 PM
SCYNEXIS and GSK Resolve MARIO Study Disagreement
SCYX
Legal Proceedings
New Projects/Investments
Guidance Update
  • SCYNEXIS will receive a $22 million payment from GlaxoSmithKline (GSK) as part of a resolution to terminate the Phase 3 MARIO study on invasive candidiasis.
  • An additional $2.3 million will be paid to SCYNEXIS for the wind-down activities associated with the MARIO study.
  • These payments, combined with the removal of future MARIO expenditures, are expected to extend SCYNEXIS's cash runway to more than two years.
  • GSK has reaffirmed its commitment to the commercialization of BREXAFEMME, with the NDA transfer to GSK anticipated by the end of 2025 and regulatory interactions for a U.S. relaunch expected in 2026.
Oct 15, 2025, 12:00 PM